Description

Retagliptin is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) primarily used in the research and development of novel antidiabetic therapeutics. Its core value lies in its role as a key building block for dipeptidyl peptidase-4 (DPP-4) inhibitors, a major class of drugs for managing type 2 diabetes. This compound is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in metabolic disease drug discovery and production.

Application

• Pharmaceutical API Synthesis: Primary use as a critical intermediate in the commercial-scale manufacturing of DPP-4 inhibitor drugs.
• Drug Discovery & Development: Serves as a reference standard and a starting material for the synthesis of new chemical entities (NCEs) targeting diabetes and related metabolic disorders.
• Biochemical Research: Used in in vitro studies to investigate the mechanism of action, selectivity, and potency of DPP-4 inhibition.
• Formulation Development: Employed in pre-formulation and formulation studies for developing stable and bioavailable dosage forms.
• Contract Manufacturing: Supplied to CDMOs for the production of finished dosage forms under current Good Manufacturing Practice (cGMP) guidelines.
• Analytical Standard: Utilized as a high-purity standard for method development and validation in quality control laboratories (e.g., HPLC, LC-MS).

Basic Information

Product Name	Retagliptin
CAS No.	1174122-54-3
Molecular Formula	C₁₉H₂₀F₃N₅O₃
Molecular Weight	423.39 g/mol
Synonyms	Retagliptin; (R)-3-Butyn-2-yl (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-(2-methyl-5-(trifluoromethyl)pyrazolo[1,5-a]pyrimidin-7-yl)-3-(trifluoromethyl)-3,4-dihydro-2H-pyrrolo[3,4-d]pyridazine-6(7H)-carboxylate; (2R,3S,5R)-5-[2-Methyl-5-(trifluoromethyl)pyrazolo[1,5-a]pyrimidin-7-yl]-2-(2,5-difluorophenyl)-3-(trifluoromethyl)-3,4-dihydro-2H-pyrrolo[3,4-d]pyridazine-6(7H)-carboxylic Acid (R)-3-Butyn-2-yl Ester; DPP-4 Inhibitor Intermediate; Antidiabetic Intermediate
EINECS	Contact for details

Quality Control

Our Retagliptin is manufactured under strict quality management systems to ensure batch-to-batch consistency and high purity suitable for pharmaceutical applications. Quality is verified through a comprehensive suite of analytical tests including HPLC for assay and impurity profiling, residual solvent analysis (GC), and spectroscopic identification. A Certificate of Analysis (COA) detailing all specifications and test results is provided with each shipment. Production can be aligned with cGMP standards for advanced clinical and commercial supply.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and handling properties. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.